Biologics

FDA’s Broadening Approval Authority Explained

Former FDAers Joshua Sharfstein and Peter Lurie say a recent agency draft guidance on benefit/risk assessment indicates that FDA “intends to embrace the broader view of its authority in certain circumstances, a promising alignment of the tools of regulation with the agency’s mission to protect public health.” Writing in a JAMA Viewpoint, the two say that under the broader approach, the agency considers the broader potential population effects, considering the risks and benefits of drug approval even for individuals who never received an appropriately prescribed dose.

The article says the expanded approach has its roots in the opioid epidemic, during which FDA encountered criticism that it fueled the crisis through overly permissive regulation of new prescription opioids. Sharfstein and Lurie say regulatory decisions were based on evaluations of the risks and benefits to people who received appropriate prescriptions of opioid products.

“As opioid-related deaths increased,” they write, “the view that the public health consequences of opioid addiction and diversion were secondary in FDA regulatory decision making became less tenable.”

The article says the new draft guidance goes beyond the confines of opioids. It discusses the guidance’s implications for antibiotics, vaccines, and tobacco and veterinary products.

“Making the most of this public health direction at FDA will require more details, appropriate expertise, and enhanced transparency,” Sharfstein and Lurie conclude. “FDA should determine when and how best to obtain and analyze relevant data. The agency should recruit staff with the training and experience to assess the population health implications of major policy decisions and should refer complicated questions for input from public advisory committees.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome